Environmental Monitoring in the Pharmaceutical Sector

PROGRAM

09:00 – 13:00 MORNING SESSION
14:00 – 17:00 AFTERNOON SESSION

• Regulatory references and the principles of Validation
• The Annex 15 EU GMP
• The FDA guideline on process validation and Annex 15: similarities and differences between US and EU expectations
• Validation Master Plan and documentation of qualification and validation
• Application of the concepts of Risk Assessment, Design of Experiments and Statistical Process Control
• Revalidation versus Continued Process Verification and Ongoing Process Verification
• Case studies: statistical evaluation of validation data and application of statistical tools in Continued Process Verification
• Cleaning Validation: regulatory references and introduction of relevant guidelines
• Key concepts, risk management, cleaning validation plan
• Documentation
• Revalidation and verification
• Analytical method validation, sampling methods
• Definition of limits: new approach
• Development of a Cleaning Validation plan (worst case rating of products, grouping and matrixing, validation of cleaning procedure, Levels of acceptance and examination of the “worstcase”)
• Innovative aspects and concepts

Quality Assurance, Validation team, Production, Quality Control, Engineering.

The course will be carried out through live lectures. Practical examples will be showcased, providing delegates with real life examples to be applied in their daily job life.

For online trainings the access link will be sent 2-3 days before the start of the training.

5% discount for registrations within 1 month before the start of the training, 10% discount for registrations within 2 months before the start of the training. VAT not included. Please inquire for discounts for multiple registrations. Discounts are not cumulative.

Cancellation terms

In order to cancel enrolment to an event, please email info@pharmaeducationcenter.it within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.

Participant replacement

It is possible to replace a participant attendance without additional cost, simply by contacting info@pharmaeducationcenter.it. It is asked to notify the participant replacement request within 5 days before the starting date of the course/event, specifying the full name and surname of the enrolled participant as well as the full name and surname of the substitute.

Training cancellation

If the minimum number of participants is not reached, Pharma Education Center reserves the right to cancel or schedule the event for another date. Formal communication will be given within 5 days before the event date. In this case Pharma Education Center will refund the registration fee in full and without additional charges. Alternatively, the participant can request a spendable coupon for participating in another PEC event scheduled in the current year.